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Am Heart J. 2015 Nov;170(5):945-50. doi: 10.1016/j.ahj.2015.07.031. Epub 2015 Aug 15.

Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

Author information

1
Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden. Electronic address: matthias.gotberg@med.lu.se.
2
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
3
Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland.
4
Department of Radiology, Helsingborg County Hospital, Helsingborg, Sweden.
5
Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
6
Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
7
Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
8
Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden.

Abstract

BACKGROUND:

Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up.

DESIGN/METHODS:

iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality.

DISCUSSION:

The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02166736.

PMID:
26542503
DOI:
10.1016/j.ahj.2015.07.031
[Indexed for MEDLINE]

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